Announcements

Apnimed Announces Dosing of First Patient in Phase 2 MARIPOSA Confirmatory Trial of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea (OSA)

12/24/2021

– Study to Inform Phase 3 Program Design of AD109 and Advance Program for AD504 – Topline Results Expected Mid-2022 Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced the dosing of the first patient in the…

Read More

Passage Bio Announces Positive Interim Safety and Biomarker Data and Advances Phase 1/2 Trial of PBGM01 in GM1 Gangliosidosis

12/23/2021

– Independent Data Monitoring Committee recommends proceeding with two additional planned patient cohorts, which are now being recruited in parallel – Positive safety profile, including no serious adverse events, no complications related to intra-cisterna magna injection and no evidence of dorsal root ganglion toxicity – Intra-cisterna magna delivery resulted in substantial increases in beta-galactosidase enzyme…

Read More

EVUSHELD long-acting antibody combination retains neutralizing activity against Omicron variant in independent FDA study

12/23/2021

Only antibody authorized in the US for pre-exposure prophylaxis of COVID-19 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca’s EVUSHELD (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination for the prevention of COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant (B.1.1.529), according to new preclinical data. In this study,EVUSHELD’s Inhibitory Concentration 50 (IC50), a measure…

Read More

Notable Presents Clinical Validation Data from Two Phase 2 Trials in Adult and Pediatric Acute Myelogenous Leukemia at the 63rd American Society of Hematology (ASH) Annual Meeting

12/23/2021

-Studies demonstrate high correlation between predicted response by Notable’s predictive precision medicines platform and actual clinical response, short-term and at one year- -Interim analyses of studies with MD Anderson Cancer Center and Texas Children’s Hospital investigators corroborate platform prediction data from Standford University collaboration- Excerpt from the Press Release: FOSTER CITY, Calif.–(BUSINESS WIRE)–Notable Labs, Inc.…

Read More

Vaxart to Test Cross-Reactivity of its COVID-19 Oral Tablet Vaccine Against Omicron

12/22/2021

Cross-reactivity will be assessed using samples from Phase II clinical participants and in a parallel animal challenge study Oral tablet’s immunogenicity profile suggests it may provide cross-protection against SARS-CoV-2 variants, including Omicron Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 16, 2021 (GLOBE NEWSWIRE) — Vaxart, Inc. (NASDAQ: VXRT) said today it plans to…

Read More

Kura Oncology Doses First Patient in Phase 1/2 Clinical Trial of Tipifarnib in Combination with Tipifarnib in Head and Neck Squamous Cell Carcinoma

12/22/2021

– Preclinical data suggest HRAS and PI3Kα are co-dependent oncogenes in HNSCC – – Combination has potential to address up to 50% of patients with HNSCC – – Initial cohort comprised of patients with PIK3CA-dependent HNSCC – SAN DIEGO, Dec. 16, 2021 (GLOBE NEWSWIRE) —  Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed…

Read More

Artax Biopharma Announces First-in-Human Dosing in Phase 1 Clinical Trial for AX-158, Company’s First-in-Class Oral Immunomodulator to Treat T Cell-Mediated Diseases

12/22/2021

The Phase 1 Trial, Expected to Conclude in 2022, Will Evaluate Safety, Exposure, and Pharmacokinetics of AX-158 in Healthy Volunteers AX-158, a Novel, Oral Small Molecule Immunomodulating Agent for the Treatment of T Cell- Mediated Diseases, Selectively Modulates T Cell Responses without Suppression of Immune System Function Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 15,…

Read More

Cullinan Oncology Announces Updated Phase 1/2a Data for CLN-081 in NSCLC EGFR Exon 20 Patients

12/21/2021

CLN-081 continues to demonstrate a differentiated clinical profile at the recommended Phase 2 dose of 100mg BID Continued high response rate with favorable safety and tolerability profile observed in heavily pre-treated patients at 100mg BID Encouraging durable responses and progression free survival at 100mg BID Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 16, 2021…

Read More

Forma Therapeutics’ Investigational Olutasidenib in Combination with Azacitidine Yields Durable Complete Remission in Patients with mIDH1 Acute Myeloid Leukemia

12/21/2021

First Phase 2 combination trial results presented in oral session at 2021 ASH Annual Meeting Olutasidenib with azacitidine well tolerated with a safety profile largely consistent with olutasidenib alone ​ Molecular characteristics of olutasidenib monotherapy response reported in ASH poster presentation Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Dec. 16, 2021– Forma Therapeutics Holdings, Inc.…

Read More

Rubius Therapeutics to Highlight the Power of its RED PLATFORM®, Significant Advances Across Red Cell Therapeutic Oncology Pipeline and New Type 1 Diabetes Program at Platform and Pipeline Day

12/21/2021

Highly Versatile and Programmable RED PLATFORM Enables Multiple Modalities to Target Different Immune Pathways Across a Range of Diseases Demonstrated Tolerance Induction with Bystander Suppression in Type 1 Diabetes Preclinical Program with Findings Translatable to Multiple T Cell-Mediated Autoimmune Diseases Advancing Next-Gen Artificial-Antigen Presenting Cells (aAPCs) with Loadable MHC Class 1 Platform, Enabling Presentation of…

Read More